Clinical pharmacology of predisintegrated ibuprofen 800 mg tablets: an endoscopic and pharmacokinetic study.
Thirty-five healthy adults were randomized to receive either: (1) ibuprofen 800 mg tablets; (2) ibuprofen 800 mg aqueous suspension; (3) ibuprofen 800 mg orange juice suspension; or (3) 325 mg aspirin tablets. All treatments were tid for 7 days. Pharmacokinetic sampling was conducted on days 1, 4 and 8. Gastroduodenoscopy was performed on days 1 and 8. Side effects and safety laboratory tests were monitored throughout the study. On day 8 the aspirin group showed significantly more gastric irritation than all of the ibuprofen groups (P less than .005). Both ibuprofen suspension groups showed more gastric irritation than the ibuprofen tablet group (P less than .1). The duodenal scores did not differ among the treatment groups. The aspirin group experienced a higher rate of tinnitus and abdominal pain. The rate and extent of absorption of the ibuprofen suspensions were significantly less than that of the tablets. These data suggest that the taking of ibuprofen as an extemporaneous suspension is therapeutically inferior to ibuprofen tablets and therefore should be discouraged.
Friedman
H
H
Clinical Pharmacology Unit, Upjohn Company, Kalamazoo, Michigan 49001.
Seckman
C
C
Lanza
F
F
Royer
G
G
Perry
K
K
Francom
S
S
D000328:Adult; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D001628:Beverages; D002851:Chromatography, High Pressure Liquid; D002957:Citrus; D004384:Duodenoscopy; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D005773:Gastroscopy; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D007413:Intestinal Mucosa / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D013607:Tablets; D014867:Water
D013607:Tablets; D014867:Water; D001241:Aspirin; D007052:Ibuprofen